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A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 17, 2007
Last updated: November 2, 2015
Last verified: November 2015
This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Methotrexate
Drug: rituximab [MabThera/Rituxan]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Expanded Access Program to Assess the Safety of MabThera in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Adverse event incidence and profile [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: February 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Methotrexate
>=15 mg po/week
Drug: rituximab [MabThera/Rituxan]
1g iv on days 1 and 15


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • rheumatoid arthritis >=6 months;
  • lack of response to 1-5 DMARDs or biological agents;
  • rheumatoid factor positive.

Exclusion Criteria:

  • other chronic inflammatory articular disease or systemic rheumatic disease;
  • joint or bone surgery during 8 weeks prior to randomization;
  • previous treatment with any cell-depleting therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00502996

  Hide Study Locations
Buenos Aires, Argentina, 1425
Buenos Aires, Argentina, C1280AEB
Buenos Aires, Argentina, C1426AAL
Córdoba, Argentina, 5000
San Miguel de Tucuman, Argentina, 4000
Tucuman, Argentina, 4000
Belem, Brazil, 66063-240
Brasilia, Brazil, 70322000
Brasilia, Brazil, 70390-904
Campinas, Brazil, 13015-001
Campinas, Brazil, 13025-141
Curitiba, Brazil, 80730-000
Florianopolis, Brazil, 88040-970
Fortaleza, Brazil, 60155-290
Fortaleza, Brazil, 60430-370
Goiania, Brazil, 74110010
Nova Lima, Brazil, 34000-000
Porto Alegre, Brazil, 90610-000
Recife, Brazil, 50000-000
Ribeirão Preto, Brazil, 14048-900
Rio de Janeiro, Brazil, 20551-030
Rio de Janeiro, Brazil, 21941-590
Rio de Janeiro, Brazil, 22050-000
Rio de Janeiro, Brazil, 22640102
Salvador, Brazil, 40050-410
Sao Paulo, Brazil, 03128-050
Sao Paulo, Brazil, 04026-000
Sao Paulo, Brazil, 04038-002
Sao Paulo, Brazil, 04038-040
Sao Paulo, Brazil, 04039-004
Sao Paulo, Brazil, 05403-000
Vitoria, Brazil, 29043-910
Santiago, Chile
Barranquilla, Colombia
Bogota, Colombia
Cuenca, Ecuador, 1394
Guayaquil, Ecuador
Quito, Ecuador, 1394
El Salvador
San Salvador, El Salvador
Mexico City, Mexico, 02990
Mexico City, Mexico, 06920
Mexico City, Mexico, 14080
San Luis Potosi, Mexico, 78240
Jesus Maria, Peru
Lima, Peru, 13
San Isidro, Peru, LIMA 27
Montevideo, Uruguay, 11600
Barquisimeto, Venezuela, 3005
Caracas, Venezuela, 1010
Caracas, Venezuela, 1040
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00502996     History of Changes
Other Study ID Numbers: ML19385 
Study First Received: July 17, 2007
Last Updated: November 2, 2015
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors processed this record on September 26, 2016